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Osteo Arthritis KneeNCT03502889

Single Dose Adductor Canal Block vs SPANK Block for TKA

A study testing SPANK Block (Sensory Posterior Articular Nerves of the Knee), Adductor Canal Block and Ropivacaine Hcl 0.5% Inj Vil 30Ml in people with Osteo Arthritis Knee and Pain, Postoperative, run by San Antonio Uniformed Services Health Education Consortium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective, randomized control trial to compare SPANK block combined with adductor canal block to adductor canal block alone in treatment of post-operative pain after total knee arthroplasty. Read more about this study

Who is it for?
Ages 40 to 80 yearsHealthy volunteers can take part
What is being tested?
SPANK Block (Sensory Posterior Articular Nerves of the Knee), Adductor Canal Block and Ropivacaine Hcl 0.5% Inj Vil 30Ml
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
No sites listed yet
Study dates
Jun 2019to Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients between the ages of 40 and 80 years old undergoing total knee arthroplasty amenable to peripheral nerve block for perioperative analgesia.
  • BMI <45
  • ASA class III or less

Who cannot join

  • Inability to sign consent form
  • Allergy to medications used in the study
  • Repeat surgery
  • History of seizure disorder
  • Simultaneous bilateral TKA
  • History of substance abuse
Show all 14Show fewer
  • BMI >45
  • Opioid consumption of greater or equal to 30mg morphine equivalents per day
  • Age <40 or >80 years old
  • ASA IV or greater
  • Inability to use a PCA
  • Inability to access the intrathecal space
  • Infection at the site of injection (either for spinal or PNB)
  • INR greater than or equal to 1.4

Trial locations and contacts

No sites are listed yet.

Angela M Curell, MD contact

(210) 220-7450

angela.m.curell2.mil@mail.mil

Gregory Stevens, MD contact

(210) 916-2014

gregory.j.stevens.mil@mail.mil

About this study

Official title: Single Dose Adductor Canal Block With SPANK (Sensory Posterior Articular Nerves of the Knee) Block Compared to Single Dose Adductor Canal Block and Pain Control After Total Knee Arthroplasty

This is a prospective, randomized control trial to compare SPANK block combined with adductor canal block to adductor canal block alone in treatment of post-operative pain after total knee arthroplasty. The primary outcome is pain control, which will be measured throughout the post-operative course using morphine equivalents of opioid analgesics used during the first 24 hours after surgery. Secondary outcomes include pain scores recorded at 4, 8, 12, 16, 20, and 24 hours post-operatively, cumulative pain score, incidence of post-operative nausea and vomiting, and extent of motor blockade. The study will aid in answering the question of whether SPANK block is an effective adjunct in preventing pain and decreasing opioid requirement after TKA.

Being tested
SPANK Block (Sensory Posterior Articular Nerves of the Knee), Adductor Canal Block, Ropivacaine Hcl 0.5% Inj Vil 30Ml, Pajunk sonoplex stim needle
Keywords
Total Knee Arthroplasty, SPANK Block, Adductor Canal Block, Regional Anesthesia
Medical subject headings
Pain, Postoperative, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPANK Block (Sensory Posterior Articular Nerves of the Knee)Procedure or surgery

    Injection of local anesthetic into the tissues on the posterior aspect of the knee to provide sensory blockade of the articular nerves of the knee.

  • Adductor Canal BlockProcedure or surgery

    Injection of local anesthetic into the inner thigh under ultrasound guidance to provide sensory blockade to the anterior aspect of the knee

  • Ropivacaine Hcl 0.5% Inj Vil 30MlDrug

    Amide local anesthetic, this concentration is commonly used to achieve surgical level anesthesia. The drug itself is not being studied and the same concentration will be used in all participants.

  • Pajunk sonoplex stim needleDevice

    Echogenic needle used for ultrasound guided nerve blockade.

Study groups in NCT03502889
Study groupRoleWhat they receive
Adductor Canal Block AloneActive comparatorControl arm to receive Adductor Canal Block without additional interventions Intervention: ropivacaine 0.5% 15cc injected under ultrasound guidance
Receives: Procedure: Adductor Canal Block; Drug: Ropivacaine Hcl 0.5% Inj Vil 30Ml; Device: Pajunk sonoplex stim needle
SPANK Block Plus Adductor Canal BlockExperimentalExperimental arm to receive Adductor Canal Block plus SPANK Block (Sensory Posterior Articular Nerves of the Knee) without additional interventions Intervention: ropivacaine 0.5% 15cc injected under ultrasound guidance into the adductor canal plus 20cc ropivacaine 0.5% injected into the posterior tissues of the knee
Receives: Procedure: SPANK Block (Sensory Posterior Articular Nerves of the Knee); Procedure: Adductor Canal Block; Drug: Ropivacaine Hcl 0.5% Inj Vil 30Ml; Device: Pajunk sonoplex stim needle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Opioid Consumption

    Amount of opioids used within the first 24 hours post-operatively, starting from when the patient leaves the operating room, measured in PO morphine equivalents

    Measured: 24 hours postoperatively

Secondary outcomes (2)

  1. Postoperative Pain Scores

    Verbal pain score measured via numerical rating scale from 1-10 at 4 hrs, 8 hrs, 12hrs, 16hrs, and 24 hours.

    Measured: 4, 8, 12, 16, and 24 hours postoperatively

  2. Time to first opioid use

    The amount of time measured from when the patient leaves the operating room to the time when they receive their first dose of any opioid medication.

    Measured: 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2018
  2. Study startJun 2019 (estimated)
  3. Primary completionApr 2020 (estimated)
  4. Study completionJun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03502889
Sponsor's protocol ID
SPANK Block
Status last verified
Apr 2019
First submitted
13 Mar 2018
Last updated
16 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: If shared, will plan to provide. All IPD that underlie results in publication * Study Protocol * Statistical Analysis Plan (SAP) * Informed Consent Form (ICF) * Clinical Study Report (CSR) Starting 6 months after publication

Publications

  • Terkawi AS, Mavridis D, Sessler DI, Nunemaker MS, Doais KS, Terkawi RS, Terkawi YS, Petropoulou M, Nemergut EC. Pain Management Modalities after Total Knee Arthroplasty: A Network Meta-analysis of 170 Randomized Controlled Trials. Anesthesiology. 2017 May;126(5):923-937. doi: 10.1097/ALN.0000000000001607.

    PubMed 28288050

  • Gao F, Ma J, Sun W, Guo W, Li Z, Wang W. Adductor Canal Block Versus Femoral Nerve Block for Analgesia After Total Knee Arthroplasty: A Systematic Review and Meta-analysis. Clin J Pain. 2017 Apr;33(4):356-368. doi: 10.1097/AJP.0000000000000402.

    PubMed 27322397

  • Wang D, Yang Y, Li Q, Tang SL, Zeng WN, Xu J, Xie TH, Pei FX, Yang L, Li LL, Zhou ZK. Adductor canal block versus femoral nerve block for total knee arthroplasty: a meta-analysis of randomized controlled trials. Sci Rep. 2017 Jan 12;7:40721. doi: 10.1038/srep40721.

    PubMed 28079176

  • Karlsen AP, Wetterslev M, Hansen SE, Hansen MS, Mathiesen O, Dahl JB. Postoperative pain treatment after total knee arthroplasty: A systematic review. PLoS One. 2017 Mar 8;12(3):e0173107. doi: 10.1371/journal.pone.0173107. eCollection 2017.

    PubMed 28273133

  • Li D, Ma GG. Analgesic efficacy and quadriceps strength of adductor canal block versus femoral nerve block following total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2016 Aug;24(8):2614-9. doi: 10.1007/s00167-015-3874-3. Epub 2015 Nov 26.

    PubMed 26611901

  • Bauer MC, Pogatzki-Zahn EM, Zahn PK. Regional analgesia techniques for total knee replacement. Curr Opin Anaesthesiol. 2014 Oct;27(5):501-6. doi: 10.1097/ACO.0000000000000115.

    PubMed 25111605

  • Pelt CE, Anderson AW, Anderson MB, Van Dine C, Peters CL. Postoperative falls after total knee arthroplasty in patients with a femoral nerve catheter: can we reduce the incidence? J Arthroplasty. 2014 Jun;29(6):1154-7. doi: 10.1016/j.arth.2014.01.006. Epub 2014 Jan 16.

    PubMed 24581899

  • Baratta JL, Gandhi K, Viscusi ER. Perioperative pain management for total knee arthroplasty. J Surg Orthop Adv. 2014 Spring;23(1):22-36. doi: 10.3113/jsoa.2014.0022.

    PubMed 24641894

  • Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.

    PubMed 24401769

  • Wasserstein D, Farlinger C, Brull R, Mahomed N, Gandhi R. Advanced age, obesity and continuous femoral nerve blockade are independent risk factors for inpatient falls after primary total knee arthroplasty. J Arthroplasty. 2013 Aug;28(7):1121-4. doi: 10.1016/j.arth.2012.08.018. Epub 2012 Dec 21.

    PubMed 23265274

  • Feibel RJ, Dervin GF, Kim PR, Beaule PE. Major complications associated with femoral nerve catheters for knee arthroplasty: a word of caution. J Arthroplasty. 2009 Sep;24(6 Suppl):132-7. doi: 10.1016/j.arth.2009.04.008. Epub 2009 Jun 24.

    PubMed 19553071

Questions about this trial

What is this clinical trial studying?

A study testing SPANK Block (Sensory Posterior Articular Nerves of the Knee), Adductor Canal Block and Ropivacaine Hcl 0.5% Inj Vil 30Ml in people with Osteo Arthritis Knee and Pain, Postoperative, run by San Antonio Uniformed Services Health Education Consortium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Angela M Curell, MD ((210) 220-7450, angela.m.curell2.mil@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Opioid Consumption (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03502889, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.

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